February 22, 2012
On February 9, 2012, the U.S. Food and Drug Administration (FDA) released draft guidance to implement the directives in the Patient Protection and Affordable Care Act (“Affordable Care Act”), signed into law in 2010. The FDA released three draft documents to assist industry in developing biosimilar products in the United States: 1) Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; 2) Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; and 3) Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product.
Historically, biological drug products did not face generic biosimilar competition because the FDA did not have authority to approve biosimilar products. This changed with the Affordable Care Act, which directed the FDA to create a system for approving biosimilar drugs. The 2010 law created an abbreviated approval pathway under Section 351(k) of the Public Health Service Act (“PHS Act”) for biological products that are highly similar (“biosimilar”) to or interchangeable with an FDA-licensed biological product. These new statutory provisions is also referred to as the Biologics Price Competition and Innovation Act (“BPCI Act”).
An FDA news release explains "biological products are therapies used to treat diseases and health conditions" and "include a wide variety of products including vaccines, blood and blood components, gene therapies, tissues and proteins.” Biological products generally are made from human and/or animal materials, as distinguished from most prescription drugs made from chemical processes. According to the FDA, "a biosimilar is a biological product that is highly similar to an already approved biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biological product in terms of safety, purity, and potency."
The FDA guidance explains that the new provisions in the BPCI Act, enacted as part of the Affordable Care Act, establish procedures for identifying and resolving patent disputes involving applications for biosimilars filed under section 351(k) of the PHS Act. Whether the new law and regulations to implement it will spur development of biologics to extend the exclusivity of a traditional “blockbuster” drug product remains to be seen.
The FDA conducted a webinar meeting on February 15, 2012, and published the slides from the meeting to provide additional insight into the agency’s current interpretation of the statutory provisions pertinent to biosimilar products.
The FDA will seek public comment on the draft guidance documents for 60 days from when the FDA publishes notice with instructions for submitting comments in the Federal Register.
Fitch Even attorneys are reviewing the proposed guidelines and will provide further details in upcoming news alerts. If you have any questions regarding these guidelines, please contact Fitch Even partner Kendrew H. Colton, the author of this alert.